Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
Background:
B-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the
system that fights infections and disease. Researchers want to learn how certain drugs work
together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone,
obinutuzumab, and lenalidomide (ViPOR).
Objective:
To study the safety of ViPOR for people with B-cell lymphoma.
Eligibility:
People ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after
treatment
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood, urine, and heart tests
- Tissue sample from previous procedure
- Imaging scans
- Registration for counseling on the risks of lenalidomide. They must get counseling at
least every 28 days.
Participants will have a bone marrow aspiration before treatment.
Participants may have tumor samples taken.
Participants will get ViPOR in 21-day cycles. For up to 6 cycles:
- Participants will get one drug by IV on days 1 and 2.
- Participants will take the other four drugs by mouth on most days. After their first
dose of venetoclax, they will stay in the clinic for at least 8 hours and return the
next day for monitoring. They may be admitted for more drugs or monitoring.
Participants will keep a drug diary.
Participants will have a physical exam and blood and urine tests at least once per cycle.
They will have scans 4 times over 6 cycles.
Participants will have a visit about 1 month after their last dose of study drug. They will
then have visits every few months for 3 years, and once a year for years 4 and 5. Visits
include a physical exam, blood tests, and scans.